FRIWO Gerätebau GmbH

FRIWO now successfully certified according to DIN EN ISO 13485

An additional quality promise to medical technology: After FRIWO has successfully passed the auditing by TÜV Nord in December 2017, the German manufacturer of power supplies has received the official certification according to DIN EN ISO 13485:2012. Backed by this independent authoritys certification, FRIWOs customers can rely upon that quality management system and development processes within the company do comply with the high regulatory requirements.

“With the certification according to ISO 13485, our teams have reached another milestone we are extremely proud of. By this demanding certification we prove to be a reliable partner for medical technology industry and we strengthen our customers confidence in our performance and efficiency”, states Rolf Schwirz, Managing Director for FRIWO, with satisfaction.

DIN EN ISO 13485 defines regulatory requirements for a comprehensive management system of medical product manufacturers. As an internationally accepted standard, this regulation contains guidelines concerning construction and development, production, installation, maintenance, and distribution. This certification imposes high levels for the exact adherence to all process steps. Special attention is paid to consequent and complete documentation and risk management; not only concerning minimization of risks, but also an optimal traceability of products and components.